A little over four years after being sued by the United States, Teva is putting longstanding allegations that it paid kickbacks on a popular multiple sclerosis drug to bed.
Teva Pharmaceuticals USA and Teva Neuroscience have agreed to pay a combined $450 million to resolve claims that the company violated the country’s Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the U.S. Department of Justice said Thursday.
The first $425-million tranche of the settlement covers claims that Teva leveraged two assistance foundations to fund patients’ copays for the blockbuster multiple sclerosis (MS) drug Copaxone from 2006 through 2017. During that period, the Justice Department contends Teva “steadily” raised Copaxone’s price.
Meanwhile, Teva will shell out another $25 million to resolve separate allegations that it conspired with other generic drugmakers to fix prices on the cholesterol med pravastatin as well as clotrimazole for fungal infections and the antibiotic tobramycin.
“Teva is pleased to put these matters behind us so we may continue to focus our efforts on developing and providing access to medicines for patients who need them through the success of our Pivot to Growth strategy,” a company spokesperson told Fierce Pharma over email.
She added that the settlements “include no admission of wrongdoing,” and noted that Teva will pay out the $450-million sum over six years.
“With respect to the PAP, we maintain that Teva’s donations supported MS patients’ access to critical medicines,” she said. “In both matters, Teva disputes that it caused false claims for reimbursement to be submitted to any government programs.”
The U.S. has had its eye on Teva’s Copaxone dealings since the summer of 2020 when the Justice Department filed a false claims lawsuit detailing the alleged kickbacks.
The case never went to trial and, in June, Teva lawyers wrote in a filing that the parties in the lawsuit were “actively engaged in settlement negotiations,” according to a Reuters report.
The United States specifically alleged that Teva “coordinated and conspired” with a specialty pharmacy and two “allegedly independent” copay assistance foundations to funnel donations toward the copays of Copaxone patients on Medicare.
Apart from the original Copaxone case in Massachusetts, seven private Medicare coverage providers in August brought a new lawsuit against Teva’s purported copay scheme in a Kansas court.
The complaint claimed Teva used The Assistance Fund and the Chronic Disease Fund—not as charities—but as “pass-through vehicles” to give money to Copaxone patients and drive up revenues for the product.
As for the price-fixing charge, the U.S. contends that Teva colluded with three other generics companies to set the costs of pravastatin, clotrimazole and tobramycin.
Teva previously entered a deferred prosecution agreement on the matter with the Justice Department’s Antitrust Division, paying a criminal penalty of $225 million. That penalty is separate and on top of the $450 million Teva agreed to hand over this week.
The settlement amount is based on Teva’s ability to pay, the Justice Department said.
Teva has been going back and forth on the Copaxone case with the U.S. for years.
Elsewhere, the company recently inked major opioid settlements and, in early 2020, agreed to pay $54 million to settle a years-old whistleblower lawsuit claiming it paid doctors as speakers or consultants at “sham” events to prescribe Copaxone and the Parkinson’s disease drug Azilect.